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New treatment option for Microtia, Congenital
Official title Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
ClinicalTrials.gov ID: NCT07154667
What this study is testing
- What it's testing
- This study aims to improve surgical outcomes for children and young adults with ear differences severe secondary to congenital conditions (like microtia, a condition where the ear is underdeveloped), trauma (such as dog bites), or surgical resections secondary to skin cancer. The investigators have developed a novel medical device to shape cartilage into pre-determined shapes that, once assembled, assists the surgeon in creating an anatomically accurate cartilaginous ear framework, reduce surgery time, and minimize wire need.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 20
You may be able to join if
- Patients aged 5-20 years seeking to undergo surgical ear reconstruction or microtia repair under general anesthesia through NCH-FL
- Pre-existing physical deformity of the ear necessitating surgical reconstruction
- Patient of sufficient health to undergo surgery under general anesthesia
- Parental or legally acceptable representative (LAR) permission obtained for inclusion in the study; patient assent obtained where age-appropriate
- Sufficient fluency in English or Spanish to complete patient/parent surveys
You likely can't join if
- Patients who will be ≤4 years old, or ≥21 years old at time of surgery
- Patients with ear deformities do not require surgical correction
- Patient's whose ear reconstruction surgery will be performed somewhere other than Nemours Children's Hospital - Florida
- Patients determined to be in poor health to undergo surgery under general anesthesia
- Parental or LAR permission cannot be obtained, and/or patient of sufficient age and cognitive capacity declines to assent
- Lack of fluency in English or Spanish to complete patient/parent surveys
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.